← FDA DRUG APPROVALS

FDA ANDA · ANDA083559

MEPIVACAINE HYDROCHLORIDE

Sponsor: BELMORA LLC

APPLICATION
ANDA083559
TYPE
ANDA
ORIGINAL APPROVAL
1973-12-04
LATEST ACTION
1994-08-10
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

MEPIVACAINE HYDROCHLORIDEDiscontinued
MEPIVACAINE HYDROCHLORIDE 3% · INJECTABLE · INJECTION

Approval history

1994-08-10Labeling · Supplement 23AP
1993-03-04Labeling · Supplement 22AP
1990-10-25Labeling · Supplement 21AP
1989-11-29Labeling · Supplement 20AP
1988-11-03Manufacturing (CMC) · Supplement 19AP
1987-11-04Manufacturing (CMC) · Supplement 17AP
1985-01-31Manufacturing (CMC) · Supplement 13AP
1985-01-31Manufacturing (CMC) · Supplement 14AP
1983-10-20Manufacturing (CMC) · Supplement 11AP
1973-12-04OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →